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USP DI Vol. II - ERLOTINIB (Systemic)

ERLOTINIB (Systemic)


Some commonly used brand names are:

In the U.S.?

  • Tarceva

In Canada?

  • Tarceva

Category

  • Antineoplastic

Description

Erlotinib ((er-LOE-tye-nib)) belongs to the group ofmedicines called antineoplastics. It is used to treat non-small cell lungcancer after the failure of other chemotherapy treatment. It is also usedtogether with another medicine called gemcitabine (e.g., Gemzar) to treatcancer of the pancreas.

This medicine is available only with your doctor's prescription, in thefollowing dosage forms:

    Oral
  • Tablets (U.S. and Canada))


Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For erlotinib, the followingshould be considered:

Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to erlotinib. Also tell your doctor and pharmacist ifyou are allergic to any other substances, such as foods, preservatives, ordyes.

Pregnancy?Erlotinib has been shown to cause miscarriagesand death of the fetus in animals. However, this medicine may be needed inserious diseases or other situations that threaten the mother's life. Be sureyou have discussed this with your doctor.

It is best to use some kind of birth control while you are receiving erlotinib.Tell your doctor right away if you think you have become pregnant while receivingerlotinib.

Breast-feeding?It is not known whether erlotinib passes intothe breast milk. However, erlotinib is not recommended during breast-feeding,because it may cause unwanted effects in nursing babies.

Children?Studies on this medicine have been done only inadult patients, and there is no specific information comparing use of erlotinibin children with use in other age groups.

Older adults?This medicine has been tested in elderly patientsand has not been shown to cause different side effects or problems in olderpeople than it does in younger adults.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingerlotinib, it is especially important that your doctor and pharmacist knowif you are taking any of the following:

  • CYP3A4 inducers such as
  • Carbamazepine (e.g., Tegretol) or
  • Phenobarbital (e.g., Barbiturates) or
  • Phenytoin (e.g., Dilantin, Phenytek), or
  • Rifabutin (e.g., Mycobutin) or
  • Rifampin (e.g., Rifadin, Rimactane) or
  • Rifapentin (e.g., Priftin) or
  • St. John's Wort?May decrease the effectiveness of erlotinib
  • CYP3A4 inhibitors such as
  • Ketoconazole (e.g., Nizoral) or
  • Atazanavir (e.g., Reyataz) or
  • Clarithromycin (e.g., Biaxin) or
  • Indinavir (e.g., (Crixivan) or
  • Itraconazole (e.g., Sporanox) or
  • Nefazodone (e.g., Serzone) or
  • Nelfinavir (e.g., Viracept) or
  • Ritonavir (e.g., Norvir) or
  • Saquinavir (e.g., Fortovase, Invirase) or
  • Telithromycin (e.g., Ketek) or
  • Troleandomycin (e.g., TAO) or
  • Voriconazole (e.g., Vfend)?May increase the amount or erlotinibin you blood and your doctor may lower your dose of erlotinib
  • Warfarin (e.g., Coumadin) or
  • Other anticoagulants (blood thinners)?Bleeding may occur.

Other medical problems?The presence of other medicalproblems may affect the use of erlotinib. Make sure you tell your doctor ifyou have any other medical problems, especially:

  • Liver disease?The chance of serious side effects is greatlyincreased.

Proper Use of This Medicine

It is important that you take erlotinib one hour before or at least two hoursafter the ingestion of food

Dosing?The dose of erlotinib will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage doses of erlotinib. If your dose is different,do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine.

  • For oral dosage form (tablets):
    • For lung cancer, non-small cell:
      • Adults?150 milligrams (mg) daily.
      • Children?Use and dose must be determined by your doctor.
    • For cancer of the pancreas:
      • Adults?100 mg daily.
      • Children?Use and dose must be determined by your doctor.

Missed dose?If you miss a dose of this medicine, take itas soon as possible. However, if it is almost time for your next dose, skipthe missed dose and go back to your regular dosing schedule. Do not doubledoses.

Storage?To store this medicine:

  • Keep out of the reach of children.
  • Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
  • Do not keep outdated medicine or medicine no longer needed. Ask yourhealth care professional how you should dispose of any medicine you do notuse. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check you at regular visits.

It is important that you seek prompt medical attentionshould severe or persistent diarrhea, nausea, anorexia, or vomiting occur.

You should seek prompt medical attention if onset orworsening of unexplained shortness of breath or cough occur.

Contact your doctor if you develop eye irritation.


Side Effects of This Medicine

Along with its needed effects, a medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.

    Check with your doctorimmediately if any of the following side effects occur:

      More common

        Burning, tingling, numbness or pain in the hands, arms, feet,or legs; cough; diarrhea,severe; difficult or labored breathing; fever; rash, severe; sensation of pins and needles; shortness of breath; stabbing pain; tightnessin chest; wheezing

      Rare

        Bloody or black, tarry stool; blurredvision; chest pain or discomfort; constipation; eye irritation or redness; inability to speak; pain or discomfortin arms, jaw, back, or neck; seizures; severe stomach pain; shortness of breath; slurred speech; suddenand severe headache; sudden and severe weakness inarm and/or leg on one side of the body; sudden weaknessin arms or legs; sudden, severe chest pain; sweating; temporary blindness; vomiting of blood or material that looks like coffee grounds

      Symptoms of Overdose

      Get emergency help immediately if any of the followingsymptoms of overdose occur

        Diarrhea; rash

    Other side effects mayoccur that usually do not need medical attention. These side effects may goaway during treatment as your body adjusts to the medicine. However, checkwith your doctor if any of the following side effects continue or are bothersome.

      More common

        Acid or sour stomach; belching; bloated full feeling; bone pain; burning, dry or itching eyes; diarrhea,mild; difficulty in moving; discharge; discouragement; dizziness; dryness of the eye; dry skin; excess air or gas in stomach or intestines; excessive tearing; fear; feeling sad or empty; feeling unusually cold; fever or chills; hair loss; headache; heartburn; hoarseness; indigestion; irritability; itching skin; joint pain; lack or loss of appetite; loss of interest or pleasure; lower back or side pain; muscle aching or cramping; muscle pains or stiffness; nausea; nervousness; painful or difficult urination; passinggas; rash, mild; redness,pain, swelling of eye, eyelid, or inner lining of eyelid; shivering; sleeplessness; stomach discomfort, upset, or pain; swelling; swelling or inflammation of the mouth; swollen joints; thinning of hair; tiredness; trouble concentrating; trouble or inability to sleep; unusual tirednessor weakness; vomiting; weight loss

Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your doctor.


Developed: 02/17/2005
Revised: 11/14/2005